A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes

NCT05280496 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00002576
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing whether daily metformin for 1 year postpartum can reduce risk of diabetes in patients who had gestational diabetes. Typical care for prediabetes after gestational diabetes is counseling on diet and lifestyle. This study is researching whether management of diabetes prevention is more effective with the drug metformin. This study will be conducted at Tufts Medical Center.

Conditions

Diabetes, Gestational; PreDiabetes; Diabetes Mellitus, Type 2

Keywords

gestational diabetes; diabetes risk; medical management; risk prevention; postpartum; diabetes; metformin

Outcome Measures

Primary Outcomes (2)

• HbA1C

  These results will be shared with participants and their providers. Any participants who accepted metformin but do not have diabetes will be asked to stop all study medication and no more study medication will be dispensed.

  12 months

• HbA1C

  At 15 months postpartum, study participants with prediabetes will be seen again for their final study visit. The investigators intend to follow all participants for 3 months after metformin treatment ends for both safety reasons and efficacy reasons. If the metformin was masking diabetes, the investigators want the opportunity to identify those participants and refer them for treatment. Additionally, prior studies have not determined whether the benefits of metformin extend after the medication is discontinued (as indicated by the FDA when the investigators requested to use metformin in the first year postpartum).

  15 months

Secondary Outcomes (2)

• Weight

  12 months

• Weight

  15 months

Study Arms (1)

Metformin

EXPERIMENTAL

Participants will be given a daily prescription of metformin for 12 months postpartum. At 12 months and again at 15 months (3 months off the drug), HbA1c and weight will be assessed.

Drug: Metformin

Interventions

Metformin DRUG

Metformin is used to lower blood sugar in patients with high blood sugar (diabetes).

Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women currently pregnant with planned delivery at Tufts Medical Center
• Gestational diabetes mellitus diagnosed during pregnancy
• ≥18 years of age
• Opted for the 2 hour 75 gram OGTT during postpartum hospitalization
• Willing and able to sign the informed consent

You may not qualify if:

• Unable to commit to required study visits for any reason.
• Contraindications to metformin
• Liver disease
• Impaired renal function (Creatinine Clearance\> )
• Congestive heart failure(CHF)
• Taking drugs that could interfere with metformin metabolism
• Taking metformin outside of pregnancy
• Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids).
• Decided against the 2 hour 75 gram OGTT during postpartum hospitalization.
• Preexisting diabetes mellitus.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (11)

• Charlton JM, van Heyningen R. Glucose 6-phosphate dehydrogenase in the mammalian lens. Exp Eye Res. 1971 Mar;11(2):147-60. doi: 10.1016/s0014-4835(71)80018-0. No abstract available.

  PMID: 4399293 BACKGROUND

• Carter EB, Tuuli MG, Odibo AO, Macones GA, Cahill AG. Prenatal visit utilization and outcomes in pregnant women with type II and gestational diabetes. J Perinatol. 2017 Feb;37(2):122-126. doi: 10.1038/jp.2016.175. Epub 2016 Oct 13.

  PMID: 27735930 BACKGROUND

• Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available.

  PMID: 28910846 BACKGROUND

• Asymptomatic hiatus hernia. Lancet. 1969 Apr 26;1(7600):870-1. No abstract available.

  PMID: 4180530 BACKGROUND

• Moin T, Li J, Duru OK, Ettner S, Turk N, Keckhafer A, Ho S, Mangione CM. Metformin prescription for insured adults with prediabetes from 2010 to 2012: a retrospective cohort study. Ann Intern Med. 2015 Apr 21;162(8):542-8. doi: 10.7326/M14-1773.

  PMID: 25894024 BACKGROUND

• Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE; Diabetes Prevention Program Research Group. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008 Dec;93(12):4774-9. doi: 10.1210/jc.2008-0772. Epub 2008 Sep 30.

  PMID: 18826999 BACKGROUND

• Werner EF, Has P, Rouse D, Clark MA. Two-day postpartum compared with 4- to 12-week postpartum glucose tolerance testing for women with gestational diabetes. Am J Obstet Gynecol. 2020 Sep;223(3):439.e1-439.e7. doi: 10.1016/j.ajog.2020.05.036. Epub 2020 May 26.

  PMID: 32470456 BACKGROUND

• Werner EF, Has P, Kanno L, Sullivan A, Clark MA. Barriers to Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2019 Jan;36(2):212-218. doi: 10.1055/s-0038-1667290. Epub 2018 Jul 30.

  PMID: 30060291 BACKGROUND

• Werner EF, Has P, Tarabulsi G, Lee J, Satin A. Early Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2016 Aug;33(10):966-71. doi: 10.1055/s-0036-1583193. Epub 2016 Apr 27.

  PMID: 27120481 BACKGROUND

• Whelan AR, Ayala NK, Werner EF. Postpartum Use of Weight Loss and Metformin for the Prevention of Type 2 Diabetes Mellitus: a Review of the Evidence. Curr Diab Rep. 2021 Sep 8;21(10):37. doi: 10.1007/s11892-021-01410-7.

  PMID: 34495405 BACKGROUND

• Bennett WL, Liu SH, Yeh HC, Nicholson WK, Gunderson EP, Lewis CE, Clark JM. Changes in weight and health behaviors after pregnancies complicated by gestational diabetes mellitus: the CARDIA study. Obesity (Silver Spring). 2013 Jun;21(6):1269-75. doi: 10.1002/oby.20133. Epub 2013 May 13.

  PMID: 23666593 BACKGROUND

Related Links

• The Diabetes Prevention Program

MeSH Terms

Conditions

Diabetes, Gestational; Prediabetic State; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Erika Werner, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 15, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: April 18, 2025
• Last Updated: April 20, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)